Bioprocess Technology - BioQuality

Biotechnology is one of the fastest growing industries in the United States, taking root in North Carolina and providing thousands of people with good jobs in an industry dedicated to helping others.

While job opportunities are concentrated in central North Carolina, positions are also available on the NC coast as well as in the mountains. Many bioprocess industries are located in NC where they manufacture medicines such as vaccines and antibiotics, agricultural products, and biological agents to help protect and clean our environment, improve nutrition, and increase shelf life of a variety of foods and medicines.

The BioQuality Technology program at CCCC is the only one of its kind, focusing on the foundational quality concepts needed to support the manufacturing of biological products.

With a two-year associate in applied science degree, graduates of this program can expect to be employed in entry-level positions at an annual salary range of $28,000 to $35,000. Graduates with experience in the bio-industry can earn even higher salaries. Students that currently have bio-industry experience have the option to begin with a one-year certificate program that will prepare them for higher-level jobs in this growing industry or as a refresher on the quality concepts currently used on the job. Graduates of CCCC programs are employed by industries located throughout the state, but are concentrated in Sanford, Pittsboro, Research Triangle Park, Greensboro, Clayton, Durham, and Wilmington.

The two year BioQuality Technology program introduces students to basic quality concepts used in the bio-field such as cGMP standards and regulations, quality assurance and control requirements, validation fundamentals, auditing processes, and cGMP quality systems as well as foundational bioprocessing principles and practices. They learn how these skills are put to use in supporting the quality culture of biological products manufacturing. During the program, students will become familiar with the 21 CFR documents governing the manufacture of pharmaceutical products, other FDA standards and guidance documents, the importance of validation, the audit process, and how quality systems are designed and implemented in a cGMP-regulated operation.

The one-year BioQuality Technology Certificate program is offered in its entirety via distance education. The Associate Degree program includes courses taught both on the Sanford campus and through distance education offerings.

BioQuality Technology is a great career choice in that it allows graduates to become directly involved with quality in an industry that impacts the daily life and health of many people in the community and around the world. Graduates can look forward to a challenging career that rewards employees with a good salary and great fringe benefits.

What Students Learn

Students successfully completing the BioQuality Technology Program will be able to:

Follow company procedures and FDA regulations to work safely and efficiently in the manufacturing environment.

Measure process variables involved in manufacturing including pH, temperature, pressure, flow rate, conductivity etc. Demonstrate the ability to use the instruments needed to make these measurements

Analyze process variables so as to make any necessary adjustments to the manufacturing process.

Use the proper judgments to make adjustments by the use of process equipment such as tanks, pumps, valves, seals and the piping that connects them to maintain the integrity of the product.

Demonstrate knowledge of the fermentation theory. Understand the principles of cell growth and provide the growing cells with the materials that they need to survive and manufacture product.

Support the fermentation process with the use of aseptic techniques, contamination control, environmental monitoring and the use of clean rooms so as to maintain the integrity of the product.

Demonstrate recovery of the product using techniques in cell harvesting, centrifugation, extraction, precipitation, filtration, purification and chromatography so as to produce the final product ready for any final steps.

Identify the components of a quality system and an associated audit program.

Develop quality system manuals and audit plans based on the cGMP standard.

Identify the steps in the validation process and effectively utilize sample documentation.